Vivos Inc (RDGL)

[WALLnut]

What are the Benefits of the FDA Breakthrough Devices Program?
Breakthrough device designation from the FDA can provide a vast array of benefits to medical device companies as well as patients in need. For medical device companies, having your product on the breakthrough device designation list expedites regulatory processes, providing a fast track to FDA interactions and accelerated reviews that bring life-saving devices to market sooner than the standard submission route. The expedited review for breakthrough medical devices results in faster and more efficient development timelines. From a patient’s standpoint, providing treatments and technologies that could help in ways previously felt unreachable can drastically improve the lives of countless individuals